Dry Eye DiseasePhase 2NCT06146881
Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
A Phase 2 study testing Diquafosol sodium 3% and Sodium hyaluronate 0.1% in people with Dry Eye Disease, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Diquafosol sodium 3% and Sodium hyaluronate 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Oct 2022to 15 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants
- Patients with dry eye disease
- Patients are willing to participate in the study and fill out informed consent
Who cannot join
- Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis)
- There are complications after cataract surgery
- Patients with a history of using topical medications / eye drops that are used routinely
- History of eye surgery in the last 6 months
- Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma)
- Using regular medication that trigger dry eye conditions (eg antihistamines, antidepressants, decongestants, anticholinergics) / allergy to diquafosol drugs
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
RSUPN Dr. Cipto Mangunkusumo, +213148991
About this study
Official title: The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are:
- The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery.
- The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively.
- The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment.
- The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%.
Read more
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be:
- Interviewed regarding their identity, history of illness, and symptoms of dry eye disease.
- Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP).
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Read the detailed description
The general objective of this study is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% for patient who will undergo cataract surgery. The objective is being measure by the reducing symptoms and milder signs of dry eye disease and improving vision quality in post-cataract surgery patients.
- Evaluate the percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery with diquafosol sodium 3% compared to sodium hyaluronate 0.1% in patients who want to undergo cataract surgery.
- Evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively by examining the value of break up time, corneal sensibility, keratograph and FBUP
- Evaluate tear osmolarity and MMP-9 after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
- Evaluate the difference in visual quality improvement assessed from HOA and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery.
The steps of the research examination are as follows:
- History
- Comorbid dry eye disease and screening exclusion criteria (history of smoking, previous medical history, history of hypertension, history of diabetes mellitus, history of routine medication and history of recent surgery)
- Ocular Surface Disease Index (OSDI) Questionnaire
- Physical Examination
The examination is carried out with sufficient lighting, to see if the patient's eye has other eye surface disorders that can affect dry eye syndrome. Examination of disorders of the surface of the eyeball is carried out by inspection to see the patient's ability to blink, the eyelids, eyelashes and interpalpebral surface, performing an examination by lifting the upper upper eyelid superiorly, examination by pulling the eyelid to see if the eyelid looks drooping and checking In the fornix of the eye, emphasis is placed on the expression of the meibomian glands. The existence of a positive examination, describes the patient has a disorder of the eyeball surface. This examination determines whether the patient can undergo cataract surgery for research.
- Supporting Examination
- Contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time, fluorescein break up pattern.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
- Conditions
- Dry Eye Disease
- Being tested
- Diquafosol sodium 3%, Sodium hyaluronate 0.1%
- Keywords
- Dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diquafosol sodium 3%Drug
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
Sodium hyaluronate 0.1%Drug
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Diquafosol sodium 3% group | Experimental | Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery Receives: Drug: Diquafosol sodium 3% |
| Sodium hyaluronate 0.1% group | Active comparator | Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery Receives: Drug: Sodium hyaluronate 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI questionnaire score
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively with OSDI questionnaire. The OSDI score results will be assessed. Lower scores mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Tear break up time value
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of tear break up time. Higher value in tear break up time mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Fluorescein break up pattern
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the fluorescein break up pattern. The fluorescein break up pattern results will be categorized and analyzed descriptively.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Corneal sensibility using Cochet Bonnet esthesiometer
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of corneal sensibility using cochet bonnet esthesiometer. Any changes to the value will be assessed. Higher value mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Tear osmolarity using TearLab device
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the value of tear osmolarity using TearLab device. Lower value mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Higher Order Aberrations (HOA) value using oculyzer device
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of Higher Order Aberrations (HOA) using oculyzer device to assess the corneal aberrations. Lower value mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Contrast sensitivity value using Pelli-Robson Contrast Sensitivity Chart
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of contrast sensitivity using Pelli-Robson Contrast Sensitivity Chart. Higher value mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Matrix metalloproteinase-9 value using Human MMP-9 ELISA Kit
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of matrix metalloproteinase-9 using Human MMP-9 ELISA Kit. Lower value mean a better outcome.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Keratograph device to assess tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the patients using keratograph device to assess the tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness. The results will be categorized and analyzed descriptively.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start2 Oct 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Prof. Dr. dr. Ratna Sitompul, Sp.M(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146881
- Sponsor's protocol ID
- 21050581
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
- ClinicalTrials.gov ID
- NCT06146881
- Acronym / sponsor ID
- 21050581
- Conditions
- Dry Eye Disease
- Keywords
- Dry eye disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are:
- The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery.
- The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively.
- The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment.
- The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%.
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be:
- Interviewed regarding their identity, history of illness, and symptoms of dry eye disease.
- Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP).
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Detailed description
The general objective of this study is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% for patient who will undergo cataract surgery. The objective is being measure by the reducing symptoms and milder signs of dry eye disease and improving vision quality in post-cataract surgery patients.
- Evaluate the percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery with diquafosol sodium 3% compared to sodium hyaluronate 0.1% in patients who want to undergo cataract surgery.
- Evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively by examining the value of break up time, corneal sensibility, keratograph and FBUP
- Evaluate tear osmolarity and MMP-9 after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
- Evaluate the difference in visual quality improvement assessed from HOA and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery.
The steps of the research examination are as follows:
- History
- Comorbid dry eye disease and screening exclusion criteria (history of smoking, previous medical history, history of hypertension, history of diabetes mellitus, history of routine medication and history of recent surgery)
- Ocular Surface Disease Index (OSDI) Questionnaire
- Physical Examination
The examination is carried out with sufficient lighting, to see if the patient's eye has other eye surface disorders that can affect dry eye syndrome. Examination of disorders of the surface of the eyeball is carried out by inspection to see the patient's ability to blink, the eyelids, eyelashes and interpalpebral surface, performing an examination by lifting the upper upper eyelid superiorly, examination by pulling the eyelid to see if the eyelid looks drooping and checking In the fornix of the eye, emphasis is placed on the expression of the meibomian glands. The existence of a positive examination, describes the patient has a disorder of the eyeball surface. This examination determines whether the patient can undergo cataract surgery for research.
- Supporting Examination
- Contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time, fluorescein break up pattern.
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diquafosol sodium 3% group | Experimental | Drug: Diquafosol sodium 3%Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery |
| Sodium hyaluronate 0.1% group | Active comparator | Drug: Sodium hyaluronate 0.1%Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants
- Patients with dry eye disease
- Patients are willing to participate in the study and fill out informed consent
Key exclusion criteria (6 listed)
- Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis)
- There are complications after cataract surgery
- Patients with a history of using topical medications / eye drops that are used routinely
- History of eye surgery in the last 6 months
- Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diquafosol sodium 3%Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery | Drug | Diquafosol sodium 3% group |
| Sodium hyaluronate 0.1%Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery | Drug | Sodium hyaluronate 0.1% group |
Primary outcome
OSDI questionnaire score
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively with OSDI questionnaire. The OSDI score results will be assessed. Lower scores mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Tear break up time value
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of tear break up time. Higher value in tear break up time mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Fluorescein break up pattern
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the fluorescein break up pattern. The fluorescein break up pattern results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Corneal sensibility using Cochet Bonnet esthesiometer
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of corneal sensibility using cochet bonnet esthesiometer. Any changes to the value will be assessed. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Tear osmolarity using TearLab device
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the value of tear osmolarity using TearLab device. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Higher Order Aberrations (HOA) value using oculyzer device
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of Higher Order Aberrations (HOA) using oculyzer device to assess the corneal aberrations. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Contrast sensitivity value using Pelli-Robson Contrast Sensitivity Chart
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of contrast sensitivity using Pelli-Robson Contrast Sensitivity Chart. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Matrix metalloproteinase-9 value using Human MMP-9 ELISA Kit
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of matrix metalloproteinase-9 using Human MMP-9 ELISA Kit. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Keratograph device to assess tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness
Time frame: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the patients using keratograph device to assess the tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness. The results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diquafosol sodium 3% and Sodium hyaluronate 0.1% in people with Dry Eye Disease, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natasya Claudia Santoso (+6282132348778, thristded@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI questionnaire score (time frame: 4 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.